Identity
- Trade Name
- TUBE PACK, 1/4" X 3/32" X 96" FDA UDI
- Generic Name
- Cardiopulmonary bypass system blood tubing set FDA UDI
- Device Name
- A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device. FDA UDI
- Model / Reference
- SDC08 FDA UDI
- Description
- A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device. FDA UDI
Identifiers
- Catalog Number
- SDC08 FDA UDI
- Primary DI / UDI-DI
- B066SDC080 FDA UDI
- 510(k) Number
- K801401 FDA UDI
- FDA Product Code
- DWF FDA UDI
- GMDN Term
- Cardiopulmonary bypass system blood tubing set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4210 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cardiopulmonary bypass system blood tubing set
Tube Pack, 1/4" X 3/32" X 96" by Novosci Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary bypass system blood tubing set.
- Perfusion Pack — LivaNova USA, Inc.
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Perfusion Pack — LivaNova USA, Inc.
- Perfusion Pack — LivaNova USA, Inc.
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Perfusion Pack — LivaNova USA, Inc.
Cleared under the same submission
K801401 also covers:
- 1/2" X 3/32" BULK TUBING, 100 FEET — NOVOSCI CORP.
- 1/4" X 1/16" BULK TUBING, 100 FEET — NOVOSCI CORP.
- 1/4" X 3/32" BULK TUBING GREEN, 100 FEET — NOVOSCI CORP.
- 1/4" X 3/32" BULK TUBING, 100 FEET — NOVOSCI CORP.
- 3/16" X 1/16" BULK TUBING, 100 FEET — NOVOSCI CORP.
- 3/8" X 1/16" BULK TUBING, 100 FEET — NOVOSCI CORP.
- 3/8" X 3/32" BULK TUBING, 100 FEET — NOVOSCI CORP.
- ARTERIAL LINE, 3/8" X 3/32" X 120" — NOVOSCI CORP.
- LINE, SUCTION - 1/4" X 1/16" X 150" — NOVOSCI CORP.
- LINE, SUCTION - 1/4" X 3/32" X 150" — NOVOSCI CORP.
- LINE, SUCTION W/BOOT – 1/16” WALL — NOVOSCI CORP.
- LINE, SUCTION W/BOOT – 3/32” WALL — NOVOSCI CORP.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Novosci Corp.
Sources (1)
- FDA UDI a1b13902-7c93-4aac-926a-ae69bda3b260 36 fields · synced Jun 1, 2026